Detection of Helicobacter Pylori Infection by High Resolution Endoscopy

Helicobacter-associated Gastritis Clinical Trial

Official title:

Detection of Helicobacter Pylori Infection by Non-magnifying High Resolution Endoscopy is Possible Within the Gastric Corpus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01434992
• Other study ID #: KHU-HP-2011
• Status: Completed
• Phase: N/A
• First received: September 14, 2011
• Last updated: April 19, 2012
• Start date: August 2011
• Est. completion date: January 2012

Study information

• Verified date: April 2012
• Source: Kyunghee University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Although endoscopic findings of H. pylori have been reported in the literature, there is still some debate over whether H. pylori-related gastritis can be diagnosed via endoscopic features alone. Most studies concluded that it is not possible to diagnose H. pylori-related gastritis on the basis of endoscopic findings. However, the resolution power of endoscopy has greatly improved in recent years and the exact examination of gastric mucosa was possible.

Description:

Our study aimed to achieve the following: (1) describe the H. pylori-related mucosal pattern in the gastric corpus using high-definition endoscopy; (2) evaluate the diagnostic accuracy for H. pylori detection; (3) find the optimal biopsy site for rapid urease test (RUT); (4) validate the inter- and intraobserver agreement in the assessment of endoscopic patterns.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 585
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients who underwent upper endoscopy

Exclusion Criteria:

• Age < 20 or > 70

• Severe systemic disease or advanced chronic liver disease

• Medication history of NSAID, PPI, H2 blockers or antibiotics

• History of H. pylori eradication therapy

• History of gastric surgery

• Recent history of upper GI bleeding

• Gastric or duodenal ulcer (including old scar change) during endoscopy

• Anemia (Hemoglobin level < 10mg/dL)

• Pangastritis

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter-associated Gastritis

Locations

Country	Name	City	State
Korea, Republic of	Kyung Hee University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kyunghee University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

Bah A, Saraga E, Armstrong D, Vouillamoz D, Dorta G, Duroux P, Weber B, Froehlich F, Blum AL, Schnegg JF. Endoscopic features of Helicobacter pylori-related gastritis. Endoscopy. 1995 Oct;27(8):593-6. — View Citation

Mihara M, Haruma K, Kamada T, Komoto K, Yoshihara M, Sumii K, Kajiyama G. The role of endoscopic findings for the diagnosis of Helicobacter pylori infection: evaluation in a country with high prevalence of atrophic gastritis. Helicobacter. 1999 Mar;4(1):40-8. — View Citation

Redéen S, Petersson F, Jönsson KA, Borch K. Relationship of gastroscopic features to histological findings in gastritis and Helicobacter pylori infection in a general population sample. Endoscopy. 2003 Nov;35(11):946-50. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis accuracy for predicting of Helicobacter pylori infection status		1 day	Yes
Secondary	Assessment of the clinicopathologic factors related to correct diagnosis		7 days	Yes